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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

Welcome to RegBits, a new way to get an at-a-glance look at important regulatory news stories. Today's top stories include a report that FDA's evaluation of antibiotics is lacking, a sea change in the regulation of weight loss drugs, Eli Lilly's push for regulatory harmonization, the UK's breakthrough product designation gets off the ground, and a drug with a side effect of poetry.

FDA Record on Antibiotics Lacking

A new and extensive report by Reuters shows that the US Food and Drug Administration (FDA) has evaluated just 7% of drugs on the market for their potential to lead to drug-resistant superbugs.

The report, Farmaceuticals, notes that FDA has evaluated all veterinary antibiotics since 2003 for their superbug potential, but also notes that FDA has not received "the vast majority of animal drugs now on the market, because most were approved before 2003." More than 300 drugs on the market have never been evaluated, Reuters found.

The same report also found that three poultry producers administer antibiotics to their animals that are also used to treat humans. "The practice is legal," Reuters explains, "but many medical scientists deem it particularly dangerous, because it runs the risk of promoting superbugs that can defeat the life-saving human antibiotics."

The report could put pressure on FDA to exert regulatory pressure on the use of veterinary antibiotics. To date, FDA has only established voluntary restrictions on the use of growth-promoting and preventative antibiotics. Reuters reports FDA plans to gather data about the use of antibiotics on farms starting in 2016, and The Hillreports Rep. Louise Slaughter is already calling on the agency to do more to "protect antibiotics for human use" following the report.

FDA Easing up on Weight-Loss Drugs?

Five years ago, FDA was infamously critical of weight loss drugs, wary of earlier safety problems that emerged from drugs like fenfluramine/phentermine (fen-phen), which caused fatal pulmonary hypertension and heart valve problems.

But ever since the agency sent a complete response letter to Orexigen over its weight-loss drug Contrave in 2011, the agency has seemingly had a change of heart when it comes to weight-loss drugs—and a big one, at that.

As of September 2014, FDA has now approved three drugs indicated for weight loss in obese patients:

In addition, FDA now appears poised to approve a fourth weight-loss drug, Novo Nordisk's liraglutide, after an advisory panel voted 14-1 in favor of approving the drug. Liraglutide is already marketed under the brand name Victoza for its use in patients with diabetes.

While the agency has required extensive post-approval risk monitoring studies for all approved weight-loss drugs, the fact that FDA is approving them at all could open the door for future development of weight-loss therapies.

The Cost of Inspections, Lack of Harmonization

The CEO of Eli Lilly, John Leichleiter, is throwing his and his company's support behind the new Transatlantic Trade and Investment Partnership (TTIP), which he says will speed the flow of new medicines to market around the world.

Writing in Forbes, Leichleiter says there is "much that we could do through TTIP to reduce duplication and align practices between the European Medicines Agency (EMA) and the US Food and Drug Administration." Citing the company's own data, he said that "up to 20%" of its investment in medicines goes toward satisfying differing regulatory requirements between just FDA and EMA.

"This represents a de-facto tax on innovation," he said. He also threw his support behind multi-regulator inspections, which he said could save companies a substantial amount of money. "We estimate that each GMP inspection of one of our plants costs in excess of $125,000," he said, adding that such costs were a "significant and unnecessary financial burden that adds to the cost of bringing new medicines to patients."

"Mutual recognition could cut inspections by 40 percent – freeing up resources for inspections in priority countries like India or China," he concluded.

Breakthrough Product Designation, UK Style

The UK Department of Health (DOH) has announced the selection of its first-ever "promising innovative medicine" (PIM) designation, meant to accelerate the development of medicines and allow patients to access them more quickly.

The pathway was launched in March 2014 as part of the UK's Early Access to Medicines Scheme (EAMS). Under EAMS, as soon as an "innovative and promising" drug is approved by MHRA the drug will be made available to a limited population of UK patients without first having to undergo a cost effectiveness review by the National Center for Health and Care Excellence (NICE).

The first medicine to obtain PIM status is Northwest Biotherapeutic's DCVax-L, a dendritic cell cancer vaccine. The status makes the product eligible for further consideration under EAMS.

The UK's DOH explained: "NW Bio will now continue to develop the medicine and, if proven in trials, it will be eligible to apply for step II of EAMS, meaning that patients could benefit and the company will be able to generate further data to improve the understanding of the way the drug works. It will then go through formal medicines licensing."

A Side Effect of … Poetry?

A new report outlining a side effect suffered by a patient taking an epilepsy drug harkens back to a now-famous Monty Python sketch featuring two characters, one of whom has "caught poetry."

According to The Daily Beast, the patient, whose story was recorded in the neuroscience journal Neurocase, was on a low dose of the anticonvulsant medication lamotrigine. But while the drug had the intended effects, it also left the patient with an unintended side effect: a prolific desire to write poetry.

The side effect, sometimes referred to as hypergraphia (compulsive writing), has left the patient writing upwards of a dozen items of poetry a day, The Daily Beast explained. The side effects reportedly diminished after several months.

The episode is reminiscent of a timeless Monty Python exchange:

McGough: I'm sorry. I'm afraid I've caught poetry.

Mr Bones: Oh really? Well, don't worry, sir - I used to suffer from short stories.